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Sensory Testing and Brain Imaging for Menstrual Cramps

N/A
Waitlist Available
Led By Laura Payne, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female aged 13-19 years
Access to a smartphone or email
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)
Awards & highlights

Study Summary

This trial will explore the connection between brain function, pain inhibition, and chronic pain in adolescent girls.

Who is the study for?
Adolescent girls aged 13-19 with regular menstrual cycles and period pain, who are right-handed, have a BMI of 35 or less, can read English, and have access to a smartphone or email. Parental consent is required for those under 18. Exclusions include severe mental health conditions, metal implants incompatible with MRI scans, chronic pain conditions like IBS, recent use of certain medications including stimulants and hormones.Check my eligibility
What is being tested?
The study examines the brain's response to menstrual and non-menstrual pain in teens using sensory tests and fMRI scans. It aims to identify biomarkers predicting the development of persistent or chronic pain from primary dysmenorrhea (period pain without an organic cause) over two years.See study design
What are the potential side effects?
There are no direct side effects from participating in this trial as it involves non-invasive testing such as Quantitative Sensory Testing and fMRI scanning. However, discomfort may arise from being in enclosed spaces during MRI scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a female between 13 and 19 years old.
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I have access to a smartphone or email.
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My parent can give written permission for me to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)
This trial's timeline: 3 weeks for screening, Varies for treatment, and three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in bodily pain from baseline to 12-months post baseline
Change in menstrual pain from baseline to 12-months post baseline
Conditioned pain modulation (CPM)
+6 more
Secondary outcome measures
Change in bodily pain from 12-months post baseline to 24-months post baseline
Pain
Change in gray matter volume from baseline to 12-months post baseline
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: fMRI and laboratory pain inductionExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quantitative Sensory Testing
2017
N/A
~640

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
212 Previous Clinical Trials
21,430 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,577 Total Patients Enrolled
Laura Payne, PhDPrincipal Investigator - Mclean Hospital
Mclean Hospital
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

fMRI Clinical Trial Eligibility Overview. Trial Name: NCT04685343 — N/A
Period Pain Research Study Groups: fMRI and laboratory pain induction
Period Pain Clinical Trial 2023: fMRI Highlights & Side Effects. Trial Name: NCT04685343 — N/A
fMRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04685343 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have enrollment opportunities arisen for this experiment?

"On clinicaltrials.gov, this research is still accepting participants. Initially listed on December 14th 2020 and amended August 2nd 2022, the study needs volunteers to proceed."

Answered by AI

Am I a qualified participant for this trial?

"For this clinical trial, 212 adolescent females between the ages of 13 and 19 suffering from primary dysmenorrhoea are being accepted. These patients must meet a few eligibility requirements including; self-reported menstrual cycles averaging 22 to 35 days spanning at least 6 months, access to a smartphone or email account, right handedness, Body Mass Index (BMI) under 35, fluency in English , consent/assent form filled out by both patient and parent if applicable, and more."

Answered by AI

Are individuals who are 20 years or older eligible to participate in this investigation?

"This trial has set the age range for enrollment between 13 and 19. There are 5 trials open to those under 18, while 6 studies are available for patients over 65 years old."

Answered by AI

How many participants are allowed to be involved in this investigation?

"Affirmative. According to clinicaltrials.gov, this medical investigation is actively looking for candidates; it has been advertised since December 14th 2020 and was most recently edited on August 2nd 2022. The trial requires the enrolment of 212 participants from a single location."

Answered by AI

What is the main intent behind this clinical experiment?

"The primary objective of this trial, monitored over the baseline period, is to measure white matter fibre tract values. Secondary objectives include assessing alterations in pain inhibition via changes in conditioned pain modulation (CPM) from Baseline to 12-months post baseline; investigating region-to-region connectivity strength between salience, sensorimotor, emotional arousal and default mode networks during resting states; and measuring changes in menstrual pain ratings on a 0 (no pain) - 10 (worst possible pain) scale from 12 months post Baseline to 24 months post Baseline."

Answered by AI
~53 spots leftby Dec 2025